ID

26001

Descrição

Safety and Dose Ranging Study of ALXN6000 to Treat Relapsing or Refractory CLL or MM; ODM derived from: https://clinicaltrials.gov/show/NCT00648739

Link

https://clinicaltrials.gov/show/NCT00648739

Palavras-chave

Versões (1)
  1. 04/10/2017 04/10/2017 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de outubro de 2017

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

Inglês

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsing or refractory b cll or mm
Descrição

Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Recurrent multiple myeloma | Refractory multiple myeloma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0854802
UMLS CUI [2]
C0278791
UMLS CUI [3]
C1370446
UMLS CUI [4]
C0278620
ecog performance status 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
anticipated survival of greater than 6 months.
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
female patients of childbearing potential must agree to use two forms of contraception
Descrição

Childbearing Potential Contraceptive methods Quantity

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
patients must have a standard indication for treatment of their malignancy
Descrição

Standard Indication Cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C0920425
is willing and able to give written informed consent.
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
absolute neutrophil count (anc) < 1000 x 109/l
Descrição

Absolute neutrophil count

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 50,000 x 109/l
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
pregnant or lactating women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
prior history of autoimmune hemolysis requiring therapy.
Descrição

Hemolysis Autoimmune Treatment required for

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0019054
UMLS CUI [1,2]
C0443146
UMLS CUI [1,3]
C0332121
prior history of immune thrombocytopenia.
Descrição

Autoimmune thrombocytopenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242584
active autoimmune disease requiring immunosuppressive therapy.
Descrição

Autoimmune Disease Requirement Therapeutic immunosuppression

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0021079
positive coombs' test (neither direct or indirect)
Descrição

Direct Coombs test positive | Indirect Coombs test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151569
UMLS CUI [2]
C0151570
ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
Descrição

Adrenal Cortex Hormones | Equivalent Mineralocorticoid Effect Prednisone U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001617
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C3179191
UMLS CUI [2,3]
C0032952
UMLS CUI [2,4]
C0456683
prior stem cell transplantation within 4 weeks prior to enrollment.
Descrição

Stem cell transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1504389
prior chemotherapy for the applicable malignancy within 30 days of enrollment.
Descrição

Chemotherapy Malignant Neoplasms

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0006826
neurosurgery or cranial radiation therapy within one year of enrollment.
Descrição

Neurosurgical Procedures | Therapeutic radiology procedure cranial

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0524850
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0037303
clinically significant renal, hepatic or heart disease.
Descrição

Kidney Disease | Liver disease | Heart Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0018799
Voltar ao início da página

Similar models

Eligibility B-cell Chronic Lymphocytic Leukemia NCT00648739

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Chronic Lymphoid Leukemia | Chronic lymphocytic leukaemia refractory | Recurrent multiple myeloma | Refractory multiple myeloma
Item
relapsing or refractory b cll or mm
boolean
C0854802 (UMLS CUI [1])
C0278791 (UMLS CUI [2])
C1370446 (UMLS CUI [3])
C0278620 (UMLS CUI [4])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
anticipated survival of greater than 6 months.
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Quantity
Item
female patients of childbearing potential must agree to use two forms of contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Standard Indication Cancer treatment
Item
patients must have a standard indication for treatment of their malignancy
boolean
C1442989 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
Informed Consent
Item
is willing and able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1000 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 50,000 x 109/l
boolean
C0032181 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hemolysis Autoimmune Treatment required for
Item
prior history of autoimmune hemolysis requiring therapy.
boolean
C0019054 (UMLS CUI [1,1])
C0443146 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
Autoimmune thrombocytopenia
Item
prior history of immune thrombocytopenia.
boolean
C0242584 (UMLS CUI [1])
Autoimmune Disease Requirement Therapeutic immunosuppression
Item
active autoimmune disease requiring immunosuppressive therapy.
boolean
C0004364 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0021079 (UMLS CUI [1,3])
Direct Coombs test positive | Indirect Coombs test positive
Item
positive coombs' test (neither direct or indirect)
boolean
C0151569 (UMLS CUI [1])
C0151570 (UMLS CUI [2])
Adrenal Cortex Hormones | Equivalent Mineralocorticoid Effect Prednisone U/day
Item
ongoing corticosteroid treatment equivalent to the mineralocortacoid potency of 10 milligram (mg) /day of prednisone, or greater, for any condition.
boolean
C0001617 (UMLS CUI [1])
C0205163 (UMLS CUI [2,1])
C3179191 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Stem cell transplantation
Item
prior stem cell transplantation within 4 weeks prior to enrollment.
boolean
C1504389 (UMLS CUI [1])
Chemotherapy Malignant Neoplasms
Item
prior chemotherapy for the applicable malignancy within 30 days of enrollment.
boolean
C0392920 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Neurosurgical Procedures | Therapeutic radiology procedure cranial
Item
neurosurgery or cranial radiation therapy within one year of enrollment.
boolean
C0524850 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C0037303 (UMLS CUI [2,2])
Kidney Disease | Liver disease | Heart Disease
Item
clinically significant renal, hepatic or heart disease.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0018799 (UMLS CUI [3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial